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OpenTrials
Completed

NCT Number: NCT03021356

Comparison of TrIfecta and Perimount Magna Ease

The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.

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Key information

Conditions

Aortic Xenograft Hemodynamics

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 18 and 75 years
  • Elective aortic valve replacement in patients with predominant aortic stenosis
  • including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
  • Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
  • Native German speakers (quality of life questionnaire in German language)

Exclusion criteria

  • Isolated aortic regurgitation
  • Concomitant aortic regurgitation > 2°
  • Endocarditis
  • LVEF <40%
  • Concomitant other valve surgery
  • s/p valve surgery
  • Contraindication for stress echocardiography

Treatment and study plan

Aortic xenograft

Device

After randomization, the aortic xenograft is implanted in the standard fashion

Primary outcomes

  1. Transprosthetic pressure gradient at stress exercise echocardiography

    Time frame: Echo at follow up stress echo (at 10 months)

Secondary outcomes

  1. Transprosthetic pressure gradient at discharge echo

    Time frame: Echo at discharge (usually postoperative day 5 to 7)

  2. Left ventricular mass regression calculated by echocardiography (gram)

    Time frame: Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)

  3. Quality of life using the EQ-5D-3L questionnaire

    Time frame: 1 to 5 days before surgery and at follow up (10 months)

  4. BNP plasma level

    Time frame: 1 to 5 days before surgery and at follow up (10 months)

Sponsors and collaborators

Lead sponsor

Kerckhoff Klinik

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jan 13, 2017
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.